Point-of-Care Adipose-derived Cells for Hair Growth
ASVF-2016
2 other identifiers
interventional
8
1 country
1
Brief Summary
Androgenetic alopecia (AGA) is the most common form of hair loss and affects 50% and 23% of Caucasian men and women, respectively, over the age of 50. The percentage of men and women affected over the age of 70 increases to 80% and 60% of Caucasian men and women, respectively. Although alopecia is considered a minor dermatologic condition, it is seen as a serious condition with major life consequences by those with alopecia and has been associated with increased incidence of myocardial infarction, hypertension and hypercholesterolaemia. Androgenetic alopecia is associated with feelings of anxiety, depression and various personality disorders among men and women due to physical appearance. Depression, anxiety, aggressiveness, impaired quality of life and social inadequacy have been documented. The presence of alopecia in women is particularly stressful. ADSCs (Adipose Derived Stromal Cells), also called Stromal Vascular Fraction (SVF) cells, include regenerative cell populations derived from adipose tissue and thus are potentially important to multiple disease processes and therapeutic applications for the repair and regeneration of acute and chronically damaged tissues. It has been postulated that SVF cells may promote hair regeneration by increasing the hair-inducing ability of dermal papillae (DP) cells. The general objective of this study is to conduct a safety and feasibility study of a single injection of autologous adipose-derived SVF cells for the treatment of alopecia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2016
CompletedFirst Posted
Study publicly available on registry
April 6, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2019
CompletedMarch 25, 2019
March 1, 2019
2.3 years
March 31, 2016
March 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of treatment-emergent adverse events
Adverse events will be recorded and evaluated.
6 months
Secondary Outcomes (2)
Growth of new hair from baseline to 6 weeks, 3 months and 6 months
Changes from baseline to 6 weeks, 3 months and 6 months
Change in hair thickness from baseline to 6 weeks, 3 months and 6 months
Changes from baseline to 6 weeks, 3 months and 6 months
Study Arms (1)
Stromal Vascular Fraction Cells (SVF Cells)
EXPERIMENTALThe participants will undergo a standard tumescent liposuction to harvest adipose tissue. The adipose tissue will then be processed for obtain the Stromal Vascular Fraction Cells (SVF Cells) for a single injection for the treatment of androgenetic alopecia. Before the procedure, hair measurements will be performed in the 2cm x 2cm site for density (number of hairs per square centimeter) and thickness (mm) of the hair to compare to the measurements after the procedure at pre-procedure, 6 weeks, 3 months and 6 months.
Interventions
The procedure involves the injection of stromal vascular fraction cells (SVF Cells) into the scalp. The injection will be performed once in the middle of two perpendicular sides of a 2 x 2 cm area.
Tissue collection involving the micro-harvest of subcutaneous adipose tissue to harvest the stromal vascular fraction cells (SVF Cells).
Hair measurements will be performed using a computerized handheld USB camera at baseline, 6 weeks, and months 3 and 6 after treatment.
Eligibility Criteria
You may qualify if:
- Subjects will be in good health (ASA Class I-II) with a BMI \< 35.
- Must have at least a 2cm x 2cm spot on the scalp which shows evidence of alopecia without scarring or traumatic injury
- Able and willing to make the required study visits.
- Able and willing to give consent and follow study instructions.
- Must speak, read and understand English
You may not qualify if:
- History of bleeding disorders, anticoagulation therapy that cannot be stopped 14 days prior to injection
- Allergic to lidocaine, epinephrine, Vancomycin, cephalexins, cephalosporins, penicillins, chlorhexidine gluconate, or tattoo ink
- Individuals with a propensity for keloids
- Individuals with diminished decision-making capacity will not be included in this research study.
- Current use of anti-inflammatory or anticoagulation medications that affect bleeding or are for bleeding disorders. These include: Plavix, Warfarin (Coumadin, Jantoven, Marfarin).
- Use of concomitant treatments to improve hair growth, including topical medications, oral medications, meso-therapy, non-ablative fractional laser treatment, low-level laser therapy, interfollicular PRP injection and hair transplantation within the preceding 6 months.
- Smoking and other tobacco use.
- Pregnancy or lactating period for females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Florida
Gainesville, Florida, 32610, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Katz, MD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2016
First Posted
April 6, 2016
Study Start
October 1, 2016
Primary Completion
January 31, 2019
Study Completion
January 31, 2019
Last Updated
March 25, 2019
Record last verified: 2019-03